MODIFICATION TO INSPIRATION VENTILATOR SYSTEM


Device Classification Name

ventilator, continuous, facility use

510(k) Number K030341
Device Name MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
Original Applicant
EVENT MEDICAL LTD
6a liosban business park
tuam road
galway, 

IE

Original Contact robbie walsh
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 02/03/2003
Decision Date 01/16/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No